510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K970445Substantially Equivalent

Vitalmax 4000 Configured/vitalmax 4000 Modular/vitalmax 4100/Minipack 3100/3000/Vitalmax 800+/Minipack 300

Pace Tech Medical Monitors, Inc., Clearwater FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K970445 is the FDA 510(k) clearance record for VITALMAX 4000 CONFIGURED/VITALMAX 4000 MODULAR/VITALMAX 4100/MINIPACK 3100/3000/VITALMAX 800+/MINIPACK 300, a class II device, cleared for Pace Tech Medical Monitors, Inc. on under FDA product code MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)). FDA records list 3 510(k) clearances for Pace Tech Medical Monitors, Inc., from to . As of , FDA records show no recalls naming K970445.

Clearance record

Decision date
Received
(359 days to decision)
Product code
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Regulation
21 CFR 870.1025
Device class
Class II
Review panel
Cardiovascular
Applicant
Pace Tech Medical Monitors, Inc. 510 Garden Ave. N., Clearwater FL
510(k) summary
Statement
Third party review
No

Clearances, product code MHX

Trailing 12 months
15 clearances under product code MHX in the twelve months to October 2026, April 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code MHX, trailing twelve months
MonthClearances
November 20251
December 20251
January 20261
February 20261
March 20260
April 20263
May 20262
June 20261
July 20261
August 20263
September 20261
October 20260